TGen Drug Development (TD2) gets skills in drug manufacturing
and quality control,Rondaxe receives access to TD2's expertise in
clinical trials and regulatory navigation
SAN FRANCISCO - Feb. 18, 2010 - TGen Drug Development (TD2) and
Rondaxe Enterprises today announced a strategic alliance that will
help emerging companies speed new high-quality treatments to cancer
patients.
Rondaxe, a drug development consulting company in Syracuse, N.Y.,
helps emerging pharmaceutical and biotechnology companies navigate
through all phases of the drug development and commercialization
process. The company specializes in drug chemistry, manufacturing
and controls (CMC), quality assurance and control, regulatory
affairs and virtual business development.
TD2, a non-profit Scottsdale subsidiary of the Phoenix-based
Translational Genomic Research Institute (TGen), specializes in
guiding drug companies through the complexities of setting up and
conducting clinical trials, and moving promising drug candidates
through the federal review process of the U.S. Food and Drug
Administration.
"We are excited to work with Rondaxe, since effective CMC
management is key to the successful application and approval
processes of the FDA, and moving new anti-cancer treatments to
market where they can provide patient benefit," said Dr. Stephen
Gately, President and Chief Science Officer at TD2.
Jeffrey M. Evans, Ph.D., co-founder and managing partner of
Rondaxe, said, "Our clients will benefit measurably from the 'TD2
Solution' by receiving clear clinical and regulatory development
path guidance and service support."
Today's announcement was made during InformexUSA, the world's
leading fine and custom chemical industry trade show, which runs
through Friday, Feb. 19, at the Moscone Convention Center in
downtown San Francisco.
The TD2-Rondaxe alliance is designed to bridge a critical gap
between chemistry and translational medicine. This blend of
expertise will speed research discoveries through the regulatory
process to bring new compounds to patients in a risk-reduced and
cost-effective manner. TD2 and Rondaxe teams will focus on
maximizing their clients' value proposition throughout the early
stages of drug-development.
Rondaxe will provide drug development and manufacturing strategies
with expertise in chemical, fermentation, drug product and
analytical development, supply chain strategy, manufacturing
operations, quality control, and quality assurance.
TD2 offers an integrated suite of tools that includes preclinical
support, clinical trials and regulatory affairs, "The TD2
Solution."
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About Rondaxe Enterprises
Rondaxe Enterprises is a unique company providing a suite of
services that combines expert drug development consulting, in-depth
project management leadership, software applications and virtual
business development designed specifically for emerging
pharmaceutical and biotech companies. Rondaxe is led by four
managing members, a team of experienced industry executives and
more than 50 senior advisors, most of whom have 15-30 plus years of
industry experience, with a vision and an unflinching dedication to
clients' success. Founded in 2003, Rondaxe has enjoyed steady
growth based on a proven track record in delivering results,
establishing solid relationships with customers, and a strong
commitment to expand skills and product offerings as customer's
needs expand.
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About TGen Drug Development (TD2)
TD2, a wholly owned subsidiary of the Translational Genomics
Research Institute (TGen), is a 501(c)3 non-profit organization.
TD2 provides innovative services for oncology-focused
biopharmaceutical companies using a dedicated team of professionals
with broad experience and understanding in drug development. TD2 is
uniquely positioned to support the need for improved and
accelerated development of new chemical entities (NCE's) for
life-threatening diseases. TD2 uses a unique combination of
experience gained through its contract research organization
business, and an integrated suite of proprietary and
non-proprietary tools, preclinical study execution, regulatory
affairs assistance, clinical trial design and management, and drug
development experts to successfully move therapeutics towards
regulatory approval. TD2 is dedicated to reducing the risks and
uncertainty inherent in the drug development process. For more
information, please visit: www.td2.org.
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About TGen
The Translational Genomics Research Institute (TGen) is a Phoenix,
Arizona-based non-profit organization dedicated to conducting
groundbreaking research with life changing results. Research at
TGen is focused on helping patients with diseases such as cancer,
neurological disorders and diabetes. TGen is on the cutting edge of
translational research where investigators are able to unravel the
genetic components of common and complex diseases. Working with
collaborators in the scientific and medical communities, TGen
believes it can make a substantial contribution to the efficiency
and effectiveness of the translational process. TGen is affiliated
with the Van Andel Research Institute in Grand Rapids, Michigan.
For more information, visit: www.tgen.org.
Press Contacts:
Steve Yozwiak
TGen Senior Science Writer
602-343-8704
[email protected]
Jeffrey Evans, Ph.D.
Rondaxe Enterprises Managing Partner
315-420-0480
[email protected]
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